None listed
Conditions
Brief summary
Wrist fractures in patients are commonly managed using internal fixation. At the Royal Adelaide Hospital last year, 175 distal radius plating procedures were performed. Austofix have designed a new plate, the “VRP 2.0”, with the following proposed advantages over the current commonly available volar radial plate systems : 1. The plate is universal and not “sided” – this has beneficial effects in simplifying implant choice in theatre, as well as minimising hospital stock / inventory 2. The Locking mechanism is unique, and patented 3. The plate is lower profile than many on the market 4. The available angle for the variable angle screws has a range of 40 degrees, compared to 30 degrees for other systems. This may allow more accurate fragment specific fixation, and thus improve maintenance of fracture reduction, and hence eventual functional outcome. 5. The system offers improved instrumentation over currently used systems To confirm the clinical benefits of the Austofix VRP 2.0 plate system a combined prospective randomised controlled trial is proposed. This trial will compare outcomes of patients managed with the Austofix VRP 2.0 vs those managed with a conventional alternative. The VRP 2.0 plate is TGA registered, and on the approved list of implants with SA Health. Study Hypothesis: Adults with closed distal radius fractures who are managed operatively using the VRP 2.0 plate will perform at least 10 points better on the Patient-rated Wrist Evaluation (PRWE) score than those managed operatively using a conventional distal radius locking plate. Null hypothesis: There is no difference in clinical outcome up to one year post injury between patients managed with these 2 different plating systems. Aim: This study aims to provide high quality evidence for the effectiveness of surgical treatment of distal radius fractures using 2 different plating systems. It is proposed that the study will be conducted using a randomised controlled trial. Results will support and influence the future treatment of this common injury for optimal patient outcome.
Interventions
The intervention group will have fixation with the Austofix VRP2 distal radius plate.
Surgery will take place at the routine time and in the routine manner, undertaken by any operating surgeon from the department (at all surgical levels). The VRP2 sytem is lower profile, has more variable locking options for the screws, and is universal (ie no left or right)
Sponsors
Mark Rickman
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Investigator)
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
1. Traumatic Distal radius fracture 2. Closed injury 4. Patient medically fit for surgery 5. Ability to be followed for up to 12 months 6. Presentation within 14 days of injury
Exclusion criteria
1. Patients with concomitant injuries affecting treatment and rehabilitation of the affected arm 2. Patients with associated neurovascular injuries requiring immediate surgery 3. Patients with associated significant carpal injuries, including scaphoid fractures 4. Patient unlikely or unhappy to attend for follow up 5. Patient with limited English proficiency 6. Patient without cognitive capacity to consent and participate 7. Patients with impaired upper limb function prior to injury enough to have a DASH score of more than 30 points.
Outcome results
None listed